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CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI) (CK-SAPBI)

Primary Purpose

Breast Cancer, DCIS, Invasive Ductal Carcinoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CK Stereotactic Accelerated Partial Breast Irradiation
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • -Newly diagnosed Stage 0 or I breast cancer.
  • On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast
  • Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy
  • Age 50 years or greater
  • ER positive: (≥1% of breast tumor cells express ER in their nuclei)
  • PR (progesterone receptor) positive: (≥ 1% of breast tumor cells express PR in their nuclei)
  • Her2 negative (IHC 0-1+; for IHC 2+, FISH (fluorescence in situ hybridization) must be non-amplified)
  • Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection.
  • Negative inked surgical margins of excision or re-excision, clear of invasive tumor (no cells on ink) and DCIS by at least 1 mm
  • Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications.
  • No involved axillary lymph nodes, N0(i+) allowed
  • Enrollment and the plan to initiate of CyberKnife therapy within 12 weeks of the last breast cancer surgery.
  • Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT
  • Signed study-specific informed consent form

Exclusion Criteria:

  • -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
  • Patients with tumors greater than 2 cm
  • Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation.
  • Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be recommended to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
  • Patient with lymphovascular space invasion (LVSI).
  • Patients with involved axillary nodes.
  • Patients with collagen vascular diseases.
  • Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN-phosphatase and tensin homolog, CDH1)
  • Patients with prior ipsilateral breast irradiation.
  • Patients with prior ipsilateral thoracic irradiation.
  • Patients with Paget's disease of the nipple.
  • Patients with diffuse suspicious microcalcifications.
  • Patients with suspicious microcalcifications remaining on the post-excision mammogram.
  • Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy
  • Patients with oncoplastic reconstruction and absence of surgical clips

Sites / Locations

  • Georgetown University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment-Radiation

Arm Description

CyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days.

Outcomes

Primary Outcome Measures

The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment
Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment
Feasibility
How many patients were able to undergo CK SAPBI

Secondary Outcome Measures

Ipsilateral Breast Recurrence
No patients have recurred to date.

Full Information

First Posted
February 11, 2015
Last Updated
March 16, 2018
Sponsor
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT02365714
Brief Title
CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)
Acronym
CK-SAPBI
Official Title
A Pilot Study of Stereotactic Accelerated Partial Breast Irradiation (SAPBI) for Post-Menopausal Women (>50 y/o) With Ductal Carcinoma in Situ (DCIS) or Early Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects and cosmetic results.
Detailed Description
This study will determine the feasibility, acute and late toxicity as well as oncologic outcomes following CK-SAPBI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, DCIS, Invasive Ductal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment-Radiation
Arm Type
Other
Arm Description
CyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days.
Intervention Type
Radiation
Intervention Name(s)
CK Stereotactic Accelerated Partial Breast Irradiation
Other Intervention Name(s)
CyberKnife, SAPBI
Intervention Description
Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days.
Primary Outcome Measure Information:
Title
The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment
Description
Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment
Time Frame
Enrollment to 24 months
Title
Feasibility
Description
How many patients were able to undergo CK SAPBI
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Ipsilateral Breast Recurrence
Description
No patients have recurred to date.
Time Frame
1 month post radiation treatment through 5 years post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Newly diagnosed Stage 0 or I breast cancer. On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy Age 50 years or greater ER positive: (≥1% of breast tumor cells express ER in their nuclei) PR (progesterone receptor) positive: (≥ 1% of breast tumor cells express PR in their nuclei) Her2 negative (IHC 0-1+; for IHC 2+, FISH (fluorescence in situ hybridization) must be non-amplified) Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection. Negative inked surgical margins of excision or re-excision, clear of invasive tumor (no cells on ink) and DCIS by at least 1 mm Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications. No involved axillary lymph nodes, N0(i+) allowed Enrollment and the plan to initiate of CyberKnife therapy within 12 weeks of the last breast cancer surgery. Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT Signed study-specific informed consent form Exclusion Criteria: -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma. Patients with tumors greater than 2 cm Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation. Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be recommended to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy. Patient with lymphovascular space invasion (LVSI). Patients with involved axillary nodes. Patients with collagen vascular diseases. Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN-phosphatase and tensin homolog, CDH1) Patients with prior ipsilateral breast irradiation. Patients with prior ipsilateral thoracic irradiation. Patients with Paget's disease of the nipple. Patients with diffuse suspicious microcalcifications. Patients with suspicious microcalcifications remaining on the post-excision mammogram. Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy Patients with oncoplastic reconstruction and absence of surgical clips
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonali Rudra, M.D.
Organizational Affiliation
Georgetown University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20008
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)

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